The short version
Just 3 companies supply this market — thin enough that a single exit would be felt immediately.
The numbers behind every sentence are on this page below — and the Watch button emails you when any of them move.
Quetiapine Fumarate
quetiapine fumarate · QUETIAPINE FUMARATE 400 mg/1 · Tablet, Extended Release · Oral · Ingenus Pharmaceuticals, LLC
NDC 50742-0639-10 · 1000 TABLET, EXTENDED RELEASE in 1 BOTTLE · ANDA · View full market →
Medicare Part D
All Part D pricing →Matched to CMS's representative package for this drug (NDC 16729-0097-12) — same generic, strength, and dosage form. CMS prices one NDC per drug concept, not every package.
ⓘ How this was built
Data sources
- CMS quarterly Prescription Drug Plan Formulary & Pricing files (SPUF)
Method
Negotiated 30-day point-of-sale unit prices and formulary terms aggregated across every unsuppressed Part D and MA-PD plan for the quarter shown. Point of sale means gross of confidential rebates. CMS publishes one representative NDC per drug concept (RxCUI) rather than every package, so these figures come from CMS's representative package for the same drug — matched on generic name, strength, and dosage form. Estimated from MedPAC's program-wide rebate aggregates (June 2023: DIR = 29% of gross Part D spending; brand rebates ≈ 25–40% of gross, generics minimal). Actual rebates are confidential and vary widely by drug — this is a range, not a fact about this drug.
Pipeline and calculations built by Claude (Fable 5) from the public datasets above. Educational only — verify against primary sources before acting.
Plans pay at point of saleⓘ
$0.6555per unit
middle half $0.5122–$1.54 · 5,334 plans · Apr 1, 2026
Est. net of rebatesⓘ
≈ $0.6555
generic — rebates are minimal, so net ≈ gross
Coverage & restrictions
97%of plans cover it
tier 3 · prior auth 29% · step therapy 0% · qty limit 92%
*No drug-level rebate is public — the estimate applies MedPAC's program-wide brand rebate range to this drug's gross price. Tracked here for 10 quarters since 2024.
NADAC price per unit
No NADAC pricing on file for this NDC — NADAC covers drugs dispensed by retail community pharmacies.
Supply fragility
Not scored — fragility is computed for NADAC-priced NDCs.
90-day shortage risk (model v2)
0.1%chance of a new FDA shortage posting for quetiapine fumarate (oral solid) in the next 90 days
OAI inspection at a producing facility (24 months) · sole-source market
For scale: the typical drug’s chance is about 0.1% — this one is in ordinary territory.
Backtested statistical model over the whole market, not this package alone. Model details →
Where it's made
- analysis · label · manufacture · pack
Establishments this product's FDA label declares, located via FDA registration data. How we built this →
Regulatory
- Application
- ANDA208947
- TE code
- AB
- Approval date
- Nov 29, 2017
- Patents / exclusivity
- None on file
Shortage history
No FDA shortage reports for this drug or its presentations.
Recalls (this NDC)
No enforcement reports list this package NDC.
Manufacturers of quetiapine fumarate (Tablet, Extended Release)
| Labeler | Strength | First seen | Last seen |
|---|---|---|---|
| Accord Healthcare Inc. | QUETIAPINE FUMARATE 50 mg/1 | Jul 15, 2026 | Sep 2, 2026 |
| Accord Healthcare Inc. | QUETIAPINE FUMARATE 300 mg/1 | Jul 15, 2026 | Sep 2, 2026 |
| Accord Healthcare Inc. | QUETIAPINE FUMARATE 200 mg/1 | Jul 15, 2026 | Sep 2, 2026 |
| Accord Healthcare Inc. | QUETIAPINE FUMARATE 400 mg/1 | Jul 15, 2026 | Sep 2, 2026 |
| Accord Healthcare Inc. | QUETIAPINE FUMARATE 150 mg/1 | Jul 15, 2026 | Sep 2, 2026 |
| Ingenus Pharmaceuticals, LLC | QUETIAPINE FUMARATE 50 mg/1 | Jul 15, 2026 | Sep 2, 2026 |
| Ingenus Pharmaceuticals, LLC | QUETIAPINE FUMARATE 150 mg/1 | Jul 15, 2026 | Sep 2, 2026 |
| Ingenus Pharmaceuticals, LLC | QUETIAPINE FUMARATE 200 mg/1 | Jul 15, 2026 | Sep 2, 2026 |
| Ingenus Pharmaceuticals, LLC | QUETIAPINE FUMARATE 300 mg/1 | Jul 15, 2026 | Sep 2, 2026 |
| Ingenus Pharmaceuticals, LLC | QUETIAPINE FUMARATE 400 mg/1 | Jul 15, 2026 | Sep 2, 2026 |
| Novast Laboratories, Ltd. | QUETIAPINE FUMARATE 150 mg/1 | Jul 15, 2026 | Sep 2, 2026 |
| Novast Laboratories, Ltd. | QUETIAPINE FUMARATE 400 mg/1 | Jul 15, 2026 | Sep 2, 2026 |
| Novast Laboratories, Ltd. | QUETIAPINE FUMARATE 200 mg/1 | Jul 15, 2026 | Sep 2, 2026 |
| Novast Laboratories, Ltd. | QUETIAPINE FUMARATE 300 mg/1 | Jul 15, 2026 | Sep 2, 2026 |
Roster from daily NDC Directory diffs — first/last seen dates start July 2026.
Cite this page
DrugDashboards, "Quetiapine Fumarate — NDC 50742-0639-10," retrieved September 3, 2026, https://drugdashboards.com/drug/50742063910.
Free to cite with attribution — see how the data is put together.